The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0843-2023·Announced 2023-06-07

Fentanyl Citrate Injection Nationwide Recall Due to Manufacturing Compliance Deviations

Akorn, Inc. is recalling all lots of Fentanyl Citrate Injection nationwide due to manufacturing compliance deviations. The company was unable to complete required stability studies after ceasing operations.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall without reported illnesses or injuries. The hazard is unconfirmed product stability due to incomplete manufacturing studies, presenting theoretical risk to drug efficacy and safety.

Plain-English summary

Akorn, Inc. is recalling all lots of Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL) due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed nationwide in the United States and Puerto Rico. This is a Class II recall.

The firm went out of business and could no longer continue required stability studies for the product. Stability studies are conducted to ensure pharmaceuticals maintain their safety and efficacy throughout their intended shelf life.

Patients who are currently using this medication should consult with their healthcare provider regarding their treatment plan. Healthcare providers should review their inventory of affected lots and follow FDA guidance for managing this recall.

The recalled product

Product
Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Injectable
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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